Position Summary

生物统计师将独立地支持相对简单的临床试验的统计相关工作。日常负责对临床方案进行审阅/撰写和试验设计验证，参与CRF和数据库设计，制备分析数据集和表格的说明文件并通过SAS软件对试验输出结果做检查。

Biostatistician will work independently on simple clinical trial related tasks. The daily work includes protocol review/design, study design verification, CRF design review, preparation of specifications for analysis dataset and TFL (table, figure and listings) and output check with SAS.

Key Responsibilities

试验设计

• 对样本量计算做验证

• 审阅方案中的统计章节

• 审阅病历报告表（CRF）以及数据库设计

• 完成样本量和统计检验效能的计算

• 撰写方案中的统计分析部分

• 计划并负责数据审核会议

起草统计分析计划中空白的输出表格和图

起草简单项目的统计分析计划书

编程

• 制作分析数据库和表格的说明文件

• 执行SAS做数据检查，验证算法和输出结果

• 生成和审阅输出的表格/图形

Study design

• Verifies sample size calculations

• Reviews statistical sections of protocol

• Reviews CRF and database design

• Performs sample size and power calculations

• Writes statistical sections of protocol

• Plans and leads Data Review Meetings

Drafts SAP TLF (Table, Figure and Listing) shells

Drafts SAP text for simple projects

Programming

• Provides specifications for analysis datasets and TLFs

• Implements SAS to check datasets, verifies algorithms, outputs

• Generation and review of TLFs for delivery

Education & Experience Requirement

硕士或更高（数学，统计，生物统计或相关学科），或者在相关专业领域有适合的专业认证

硕士学位候选人需2年实际工作经验；博士学位候选人没有实际工作经验也可以考虑。

MS or PhD degree (mathematics, statistics, biostatistics, or related subject preferred), or certification in a related profession from an appropriately accredited institutions.For candidate with master degree, 2 years or above working experience is required. For PhD. candidate, no working experience is required.

Key Competency Requirement

具备相关治疗领域知识以强化对相关项目的支持

具备对非统计师解释统计概念的能力

具备对统计师和非统计师解释复杂统计概念的能力

了解GCP/ICH相关法规

中国药监局（CFDA）相关法规

CDISC CDASH/SDTM/ADAM数据标准

熟悉SAS或JMP软件

其他技能

• 演讲技能

• 团队合作能力

• 英语，书写与口语

• 沟通与交流

• 项目管理

• 问题解决能力

With knowledge of relevant TA to enhance contributions to a project

Ability to explain statistical concepts to non-statisticians

Ability to explain complex statistical concepts to statisticians and non-statisticians

Familiar with GCP/ICH guidelines

CFDA guidelines

CDISC CDASH/SDTM/ADAM data standard

SAS or JMP skill

Project/Soft Skills

• Presentation skills

• Teamwork

• English, written and verbal

• Communication

• Project management

• Problem Solving skills

备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。

上班地址：上海市浦东新区祥科路298号佑越国际，3楼301-305